Sonicision System Product Manual

1COVIDIEN ENERGY.Performance Amplified.

Sonicision System Product Manual

2The SONICISION System The industrys first cordless

ultrasonic dissection system now offers the widest portfolio and

ease of standardization

Energy whenever and wherever you want it

3Table of ContentsWhy Ultrasonic? 4

Product Overview 5

Clinical Performance 9

Procedural Application 12

Complete Product Portfolio 13

Competitive Comparison 14

Assembly and Disassembly 15

Cleaning and Sterilization 19

4Covidien has long been a pioneer in creating medical devices that use various forms of energy. Covidien Energy offers the largest energy-based, and now the most versatile cordless ultrasonic portfolio in the industry.

LigaSure Technology Ultrasonic EnergyValleylab Devices

ForceTriad Energy Platform

Bipolar

Energy and instruments for specialty procedures in gynecology, urology and neurosurgery

Laparoscopic

Vessel Sealing

Energy and instruments for hemostasis in minimally invasive surgery

Open Small Jaw

Vessel Sealing

Instrument for hemostasis and fine dissection in open surgery

Laparoscopic

Multifunction

Covidiens first multifunctional instrument for vessel sealing and monopolar dissection in minimally invasive surgery

Monopolar

Hundreds of products you use every day with over 40 years of innovation

Open Vessel

Sealing

Instruments for hemostasis in open surgery

Efficient

and Versatile

Multifunctional device offering one-step sealing, a Maryland dissector, grasper and cold scissors.

MORE ENERGY MORE PLACES

Why Ultrasonic?

With the Sonicision device, Covidien has an expanded portfolio and is a single solution

provider for energy devices.

The energy portfolio available allows complete standardization to reduce costs.

5Product OverviewThe Sonicision cordless ultrasonic dissection device is an unparalleled advancement in ultrasonic energy. The device delivers comparable clinical effectiveness associated with leading ultrasonic technologies and unique benefits from the industrys first cordless design.

The Sonicision device allows improved freedom of movement in the operating room through the innovation of cordless technology. The streamlined design features a quick and simple set up that increases O.R. efficiency.

The Sonicision device also utilizes a unique dual-mode energy activation control for seamless transition between two power modes within a single button. This intuitive design allows a surgeons eyes to remain in the surgical field rather than on the instrument for improved procedural focus.

The Sonicision system is composed of single-use and reusable components for maximum efficiency and utilization in surgical specialties that include: general (including upper gastrointestinal), bariatric, colorectal, pediatrics, gynecological and urological procedures.

The Sonicision device reliably seals vessels up to 5 mm, provides faster dissection speed2 and up to 5x less plume than the Harmonic ACE*3, and is comparable to the Harmonic ACE* and Harmonic ACE+* in thermal spread8, burst pressure11, sealing time9 and temperature.2,4,10

COMPONENTS

BATTERY CHARGERSTERILIZATION TRAY

ULTRASONIC DISSECTOR

REUSABLE GENERATOR

DUAL-MODE ENERGY BUTTON

INDICATOR LED

TORQUE WRENCH

REUSABLE BATTERY

AUDIO SPEAKER

MULTIPLE LENGTHS AVAILABLE*

14.5 MM ACTIVE BLADE

* SONICISION IS AVAILABLE WITH THE FOLLOWING SHAFT LENGTHS: 13 CM 26 CM 39 CM 48 CM

360 SHAFT ROTATION WHEEL

6Product OverviewAVAILABLE LENGTHS

ULTRASONIC DISSECTOR

Single patient use 5 mm diameter 14.5 mm active blade Dual-mode energy button (minimum and maximum)

13 CM LENGTH

Ordering Code: SCD13Order Quantity: 6 ultrasonic dissectors 13 cm (1 torque wrench included with each dissector)

26 CM LENGTH

Ordering Code: SCD26Order Quantity: 6 ultrasonic dissectors 26 cm (1 torque wrench included with each dissector)

39 CM LENGTH

Ordering Code: SCD396 SCD391 (select countries only)

Order Quantity: 6 ultrasonic dissectors 39 cm (1 torque wrench included with each dissector)

1 ultrasonic dissector 39 cm (1 torque wrench included)

48 CM LENGTH

Ordering Code: SCD48 Order Quantity: 6 ultrasonic dissectors 48 cm (1 torque wrench included with each dissector)

DISTAL MEASUREMENT MARKERS

7REUSABLE BATTERY

Ordering Code: SCGOrder Quantity: 1 battery pack

Reusable for up to 100 uses Sterilizable via low temperature hydrogen peroxide Advanced lithium polymer battery chemistry

REUSABLE GENERATOR

Ordering Code: SCGOrdering Quantity: 1 generator

Reusable for up to 100 uses Sterilizable via low temperature hydrogen peroxide Integrated LED provides device feedback

BATTERY CHARGER

Ordering Code: CBCOrder Quantity: 1 battery charger (batteries not included)

Four charging bays Supports charging of 4 batteries simultaneously

STERILIZATION TRAY

Ordering Code: SCST (U.S. customers only) SCST1 (outside U.S. customers only) Order Quantity: 1 sterilization tray

Holds one generator and one battery

Product OverviewAVAILABLE LENGTHS

8Award-Winning Device

2013 WINNER

2013 WINNER

GOLD WINNER2 0 1 3

MDEA GOLD RED DOT ESP AWARD BOULDER IQ

The Medical Design Excellence Awards (MDEA) competition is the MedTech Industrys Premier Award given to the most significant advances in medical product design and engineering of a groundbreaking product in the surgical equipment.

An international design and business competition awarded by the Design Zentrum Nordrhein, Westfalen in Essen, Germany. An internationally recognized quality label and award for excellent design selected by expert juries in the areas of product design, communication design and design concepts.

At the 2013 Excellence in Surgical Products Award, the Sonicision System won in the Best in Show category (2nd place). Based on products that have contributed to surgical performance, efficiency and safety.

The Innovation Quotient, or IQ, program honors the most innovative new products and services in Colorado. The Sonicision System won both the Innovation of the Year Award from the audience and the Business Products and Services category from a panel of judges.

Clinical Performance

OVERVIEW

The Sonicision device mean thermal spread, mean vessel burst pressure, hemostasis, mean seal time and mean peak active blade temperature are comparable to the Harmonic ACE* and Harmonic ACE+*2,4,8-11

The Sonicision device provides faster dissection speed than the Harmonic ACE*2

The Sonicision device produces up to 5x less plume than the Harmonic ACE*3

The Sonicision device provides faster active blade cool down time to 60C than the Harmonic ACE*1

The Sonicision device reliably seals vessels up to 5 mm in diameter2

BACKGROUND

Energy-based hemostatic devices have evolved over the past century to become an essential tool in surgery. The latest innovation from Covidien into this arena is the completion of the Sonicision cordless ultrasonic portfolio. Now with four available shaft lengths, inclusive of the the longest and shortest pistol grip ultrasonic device on the market with optimized ergonomic design. In turn, this portfolio utilizes advanced ultrasonic technology to provide rapid dissection and hemostasis without the need for a stand-alone generator or cord, therefore increasing the ease of operation and freedom of movement. A variety of tests have been performed to date by Covidien to evaluate the performance of the Sonicision device compared to the Harmonic ACE* and Harmonic ACE+*.

Performance of the Sonicision Cordless Ultrasonic Dissection Device compared to the Harmonic ACE* and Harmoic ACE+*.

Thermal spread, vessel burst pressure, hemostasis, seal time and blade temperature are comparable to the Harmonic ACE*

and Harmonic ACE+*2, 4, 8-119

Mean Vessel Burst Pressure (mmHg SD)2

Mean Dissection Speed

(sec SD)2

Mean Peak Active Blade Temperature

(C SD)4

Mean Active Blade Cool Down Time to 60C

(sec SD)1

Mean Thermal Spread

(mm SD)2

Mean Seal Time

(sec SD)2

Sonicision 578 284 24.8 4.9 249.7 24.3 41.2 1.3 1.06 0.05 5.2 1.7

ACE* 605 288 33.8 5.4 239.3 28.4 50.4 7.5 1.08 0.5 4.9 1.5

P-Value 0.48

The following table summarizes benchtop testing between the Sonicision device and the Harmonic ACE+*:

Mean Vessel Burst Pressure (mmHg SD)11

Mean Dissection Speed

(sec SD)10

Mean Peak Active Blade Temperature

(C SD)10

Mean Active Blade Cool Down Time to 60C

(sec SD)10

Mean Thermal Spread

(mm SD)8

Mean Seal Time

(sec SD)9

Sonicision 868.4 419.9 43.4 7.0 263.1 18.8 37.6 4.4 1.44 0.5 8.40 3.60

ACE+* 1030.1 405.1 44.6 4.3 266.3 20.2 37.4 5.8 1.25 0.2 8.12 3.74

P-Value P = 0.18 P = 0.777 P = 0.771 P = 0.704 P = 0.100 P = 0.62

Statistical Relevance

NS NS NS NS NS NS

The Harmonic Ace+* showed no statistical improvements compared to the Sonicision ultrasonic dissector.

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Procedural ApplicationsOPEN PROCEDURES

Colorectal Abdominoperineal Resection Low Anterior Resection

General Axillary Node Dissection Liver Resection Mastectomy Ventral Hernia

Gynecology Myomectomy Total Abdominal Hysterectomy

Pediatrics Appendectomy Colectomy Splenectomy

Thoracic Pneumonectomy Pulmonary Lymph Node Dissection

Urology Prostatetomy

LAPAROSCOPIC PROCEDURES

Bariatric Gastric Band Roux-en-Y Sleeve Gastrectomy

Colorectal Colectomy General Adrenalectomy Appendectomy Cholecystectomy Nissen Fundoplication Splenectomy

Gynecology Hysterectomy Lysis Pelvic Adhesions Salpingo-Oophorectomy Supracervical Hysterectomy

Thoracic Lobectomy Minimally Invasive Esphogectomy

Urology Cystectomy Nephrectomy

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Complete Product PortfolioThe right energy solution for procedural need and surgeon preference from a single manufacturer

Dissection Vessel SealingMulti-Function

Electrosurgery RF and ES RFUltrasonic

Primarily vessel sealing with some dissection

Force TriVerse

Sterile field power control

Access to Valleylab mode

Sonicision

Freedom (cordless)

Standardization

Faster set up and dissection2

LigaSure 5 mm

Proven LS performance

Independent cutting and sealing

Cooler temperature profile

LigaSure Advance II

Multi-functionality

Bariatric length (44 cm)

Valleylab mode dissection

Primarily dissection with some vessel sealing

Smaller vessels Up to 7 mm vessels

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Competitive ComparisonULTRASONIC DISSECTOR COMPARISON

Measure:

Sonicision

J&J Harmonic* ACE

J&J HarmonicACE+*

Olympus Thunderbeat*

Shaft Length - 13 cm - 26 cm - 39 cm - 48 cm

- 14 cm - 23 cm - 36 cm - 45 cm

- 23 cm - 36 cm

- 10 cm - 20 cm - 35 cm - 45 cm

Method of Activation Hand 1 button, 2 stage

Hand 2 buttons

Hand 2 buttons

Hand 2 buttons

Frequency 55.5 khz 55.5 khz 55.5 khz 47.7 khz

Jaw Length12 14.5 mm 11.1 mm 10.7 mm 16.5 mm

Total Weight of Device Assembled13 (with cords and transducer)

394.25 grams 337.47 grams 341.86 grams 386.86 grams

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2. Place torque wrench over the generator torque knob.

3. Rotate clockwise while holding rotation wheel in place until two clicks are felt or heard.

Remove torque wrench and keep in sterile field.

3

2

1. Slide the generator into the opening of the ultrasonic dissector and hand tighten clockwise while holding the shaft rotation wheel.

1

Shaft Rotation Wheel

Torque Knob

Generator

STEP 1 ATTACH AND TORQUE GENERATOR

Assembly and Disassembly

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STEP 2 ATTACH BATTERY STEP 3 TEST

1. Orient battery pack as shown. 2. Swing the battery forward and snap into place.

When properly assembled, a series of tones sound and the LED on the generator illuminates green.

1. With jaws open, activate the dual-mode energy button in minimum (half squeeze) and maximum (full squeeze) power modes.

Device is ready for use if minimum and maximum power pulsating tones are heard.

u1

2

1


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1. Remove battery by pushing up on the battery pack release latch.

2. Swing the battery toward the rear of the ultrasonic dissector to disconnect.

3. Attach new battery as shown in Step 2 above. When the device is fully assembled repeat STEP 3 - TEST.

1

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1. Clean jaw and blade (wipe with wet gauze and/or immerse in saline and activate energy with jaws open).

2. Disconnect and reconnect battery.3. Replace battery.4. Replace ultrasonic dissector.

RED INDICATOR LIGHT Device is non-functional

REPLACING BATTERY INTRAOPERATIVE TROUBLESHOOTING


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GENERATOR INDICATOR LIGHTS

Generator has reached end of life (replace generator).

Battery charge is less than 20% capacity (approximately 10-20 activations remaining upon initial notice).

Device is non-functional (see intraoperative troubleshooting section or IFU).

System is ready (minimum or maximum power).

FLASHING PURPLEFLASHING YELLOWREDGREEN


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1. Preparation for Cleaning Visually inspect the generator, battery, and sterilization tray for damage. Replace if damaged.

Prepare a solution of pH neutral, pH neutral enzymatic or alkaline detergent in accordance with the manufacturers instructions.

2. Soaking Soak the generator, battery and sterilization tray in the detergent mix for 5 to 10 minutes.

3. Manual Cleaning Manually clean the battery, generator and sterilization tray using a stiff, nylon bristle brush and the detergent solution.

Thoroughly clean the generator retention ring, generator seam, battery seam, battery pack release latch and battery contact points. Do not use abrasive cleaning agents or metal cleaning tools, such as stainless steel brushes.

Thoroughly rinse components with clean water.

4. Drying Dry generator, battery and sterilization tray with a clean, lint-free cloth. With cool, clean oil-free air, blow dry all components until completely dry.

5. Disinfecting (optional) If facility processes require disinfection prior to sterilization, wipe the surfaces of the generator, battery and sterilization tray with an isopropyl-alcohol (up to 100%) surface disinfectant.

BATTERY CONTACT POINTS

BATTERY PACK RELEASE LATCH

BATTERY SEAM

CAUTION: DO NOT wash components in automatic instrument washer or ultrasonic washer.

GENERATOR RETENTION RING

GENERATOR SEAM

Cleaning and Sterilization

CLEANING

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1. Ensure generator, battery and sterilization tray are clean and dry before sterilization.

2. Place the generator and battery in the tray.3. Cover sterilization tray base with lid and latch.4. Utilize one of the following sterilization configurations:

5. Follow these steps according to the sterile barrier selected:

Polypropylene Wrap Wrap the sterilization tray in a compatible polypropylene sterilization wrap according to the manufacturers instructions.

Single Tyvek Pouch Place the sterilization tray in a single compatible Tyvek pouch, and seal according to the manufacturers instructions.

Double Tyvek Pouch Place the sterilization tray within two compatible Tyvek pouches, and seal according to the manufacturers instructions. The Tyvek side of the inside pouch must be aligned with the Tyvek side of the outside pouch.

6. Sterilize the generator and battery within the enclosed sterilization tray using the following STERRAD* or STERIS V-PRO* models/cycles in accordance with manufacturers instructions:Model CycleSTERRAD* 100S Standard, Short or Long*STERRAD* NX* StandardSTERRAD* 100NX* StandardSTERIS AMSCO* V-PRO* 1 LumenSTERIS AMSCO* V-PRO* 1 Plus LumenSTERIS AMSCO* V-PRO* maX Lumen*Short and Long cycles are not available on 100S models sold in the United States


STERILIZING

Sterilizer Sterile Barrier

Polypropylene Wrap

Tyvek Pouch (Single)

Tyvek Pouch (Double)

STERRAD* 100S STERRAD* NX* STERRAD* 100NX* STERIS V-PRO* 1 STERIS V-PRO* 1 PLUS STERIS V-PRO* maX CAUTION: DO NOT STEAM AUTOCLAVE, FLASH or use EtO to sterilize any part of the device or accessories. Use low-temperature hydrogen peroxide sterilization only.

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Battery, Generator and Sterilization Tray

soak five to ten minutes in pH-neutral enzymztic, scrub with

a stiff, nylon bristle brush

Storing System

Store system components at 64 F to 77 F (or 18 C to 25 C). Elevated temperatures can result in reduced battery-service life.

Recharge and re-sterilize battery packs after one month of continuous storage to ensure adequate charge when needed.


STORAGE CENTRAL PROCESSING

CAUTION: Do not steam Autoclave, flash, or use EtO to sterlize any part of the device or accessories.Use low-temperature hydrogen peroxide gas plasma sterilization (i.e, STERRAD*) only.

Place components in sterilization tray and wrap

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References

1. Based on internal testing done on maximum power through 15 cm of porcine mesentery. Covidien report July 16, 2010 R0022948.

2. Tsirline VB, Lau KN, Swan RZ, Montero PN, Sindram D, Martinie JB, Iannitti DA., Evaluation of an Innovative, Cordless Ultrasonic Dissector. Surg Innov, 2013.

3. Kim FJ, Sehrt D. Pompeo A, Molina WR., Comparison of surgical plume among laparoscopic ultrasonic dissectors using a real-time digital quantitative technology. Surg Endosc. 2012.

4. Based on internal testing done on maximum power through 15 cm of porcine mesentery. Covidien report May 17, 2010 R0014725.

5. Compared to traditional capital equipment.

6. AORN Report: Brogmus G, Leone W, Butler L, Hernandez E [2007]. Best practices in OR suite layout and equipment choices to reduce slips, trips, and falls. AORN (Association of PeriOperative Registered Nurses) J 86:384398.

7. Reduction of cords improves safety in the O.R. AORN Report: Brogmus G, Leone W, Butler L, Hernandez E [2007]. Best practices in OR suite layout and equipment choices to reduce slips, trips, and falls. AORN (Association of PeriOperative Registered Nurses) J 86:384398.

8. Based on internal testing using minimum mode on isolated vessels. Covidien report Nov 18, 2013 R0047634_A.

9. Based on internal testing using minimum mode on various isolated vessels and tissue types. Covidien report Nov 18, 2013. R0047634_A.

10. 10. Based on internal testing conducting 10 consecutive device cycles on porcine mesentery. Covidien report December 12, 2013. R0047122 Rev A.

11. Based on internal testing using minimum mode on isolated vessels. Covidien report December 12, 2013 R0047124 Rev A.

12. Based on internal testing measuring the horizontal length of each jaw. Covidien report May, 2014. R0056278.

13. Based on internal testing weighing the disposable device with transducer and battery (if applicable). Covidien report May, 2014. R0056278.

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COVIDIEN, COVIDIEN with logo, COVIDIEN logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. * Trademark of its respective owner. Other brands are trademarks of a Covidien company. 2014 Covidien 10.14 US140762

The Sonicision SystemThe Science of Performance, The Ease of a Full Portfolio

5920 Longbow DriveBoulder, CO 80301United States

www.covidien.com/sonicision800-722-8772

COVIDIEN ENERGY.Performance Amplified.

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Sonicision System Product Manual